Following reports of gadolinium toxicity linked to MRI contrast dye, and concerns about the risk of deposits being left in the body, federal regulators have approved new medication guides for individuals receiving Omniscan, Magnevist and other gadolinium-based contrast agents.

Gadolinium is a heavy metal used in MRI contrast dye to help enhance the images. Although manufacturers have maintained that the gadolinium-based contrast agents are safe for individuals with normal kidney function, increasing evidence suggests that it may be retained in the body, where gadolinium may result in serious side effects.

In a drug safety communication updated on May 16, the FDA confirmed that new patient Medication Guides have been approved, which will be provided to new patients the first time they receive an MRI contrast dye.

The MRI Contrast Medication Guides come after an FDA advisory committee voted last year to recommend new warnings about the risk that gadolinium may build up in the brain.

“All MRI centers should provide a Medication Guide the first time an outpatient receives a GBCA injection or when the information is substantially changed,” the FDA indicates. However, the agency noted that hospital inpatients are not required to receive the guide unless they request it. The agency also notes that the guides should be provided to any patient that requests them.

Although the FDA indicated last year that it has not yet identified any direct evidence linking gadolinium retention to specific adverse health problems for individuals with normal kidney function, various reports have emerged about individuals suffering consistent symptoms of MRI contrast problems, which are now being described by experts as gadolinium deposition disease (GDD).

Independent reports suggest that gadolinium toxicity may result in reduced cognitive function, headaches, bone and joint pain, tendon and ligament pain, thickening of soft tissues and other problems. The condition is considered incurable and progressive, meaning that it worsens over time, raising serious concerns about the safety of gadolinium-based contrast agents widely used during MRI and MRA examinations.

The new Medication Guides indicate: “It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidneys. Rarely, patients have reported pains, tiredeness, and skin muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium.”

Gadolinium MRI Contrast Toxicity

Warnings about risks associated with the use of Omniscan, Magnevist and other gadolinium contrast dyes among individuals with an acute kidney injury or chronic kidney disease were previously issued about 10 years ago. However, gadolinium deposition disease is seen among patients with normal kidney function.

The FDA recommended that health care professionals consider the fact that the body retains gadolinium when deciding whether to give it to patients that may be at higher risk of health problems. These include women who are pregnant or think they may be pregnant, patients with kidney problems, children, and patients when inflammatory conditions. The recommendations also suggest that repeated use of the contrast agents be minimized where possible, particularly when MRIs are scheduled closely together.

Patients are now urged to tell their health care professionals whether they are pregnant or may be pregnant, whether they have kidney problems, and the date of their last MRI with gadolinium, or whether they have had repeated MRI scans that involved the use of gadolinium contrast agents.

In recent months, a growing number of gadolinium MRI contrast lawsuits have been filed on behalf of individuals who claim they have been left with painful and debilitating injuries due to the toxic retention of gadolinium in their body or brain. Plaintiffs allege that they may have avoided the problems if warnings had been provided earlier by the manufacturers.